KLS MARTIN
10 mm Obwegeser Mandibular Channel Retractor, 7 in. (18 cm)
Processing KLS Martin L.P. Surgical Instruments, Trays, and Cases
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KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 904.641.7746 • 800.625.1557 • Fax: 904.641.7378 www.klsmartinnorthamerica.com
Processing KLS-Martin L.P. Surgical Instruments, Trays, and Cases The Symbol Glossary is located on the last page of this IFU. The following recommendations are for the processing of KLS-Martin L.P. surgical devices sold in the United States and Canada:
• Instruments labelled for single-use provided sterile and non-sterile. • Reusable surgical instruments, trays, and cases.
KLS-Martin L.P. devices must be cleaned and sterilized prior to initial use for single-use devices provided non-sterile and prior to initial and subsequent uses for reusable surgical instruments, trays, and cases. Immediately upon receipt, the goods must be verified as complete and correct. Please follow the validated hospital processing procedure (handling, cleaning, disinfecting, sterilization) for KLS-Martin L.P. surgical items.
Caution
• Do not use steel wool, wire brushes or abrasive cleaners. • Avoid solutions containing bleach or corrosive cleaners. Only place KLS-Martin L.P. devices with similar metallic composition together in an ultrasonic cleaner. • Soiled or used KLS-Martin L.P. devices should not be loaded in a case and cleaned in a mechanical washer. • Intricate parts with blind holes or long, narrow cannulation require particular attention during cleaning. • All devices must be thoroughly cleaned. • KLS-Martin L.P. does not recommend or support the immediate-use steam sterilization method for KLS-Martin L.P. instruments. • KLS-Martin L.P. instruments are critical devices and must be terminally sterilized prior to use. • The sterilization parameters are only valid for devices that are adequately cleaned. • The following information is only valid for properly installed, maintained, calibrated, and compliant reprocessing equipment. • The recommended cleaning method for power equipment is manual. Do not place power equipment in an ultrasonic cleaner. Do not submerge power equipment in aqueous solutions. • Possible danger of injury to the patient from residues on the medical device. • Possible danger of injury to the patient due to infection caused by fragments. • Possible danger of injury to the patient when combining different systems.
Warnings
• Possible danger to life of patient, user and third parties if these Instructions for Use are not observed. • Possible danger to the life of others by shipping soiled products. In case of return shipments, send only clean and sterilized products in sterile packaging. • Possible danger of injury to the patient due to improper handling. Improper handling of instruments can cause the product to fail and lead to injuries. • Possible danger to the life of patients, users and others when these Instructions for Use are disregarded. • Possible danger of injury to the patient due to incompatible accessories. The instruments must never be used with incompatible accessories. • Non-sterile handling can result in danger to the life of the patient. Products supplied in non-sterile condition must be cleaned and sterilized before the first application. • Possible danger to the life of the patient due to cleaning and sterilization of used single-use products.
Limits On Reprocessing
• Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effect on KLS-Martin L.P. surgical reusable instruments. • Single-use devices must be processed according to these instructions, but must not be used a second time. • Single-use instruments that are supplied in non-sterile condition must be cleaned and sterilized before initial use. • Single-use instruments are intended for single use in one patient. • Single-use instruments must be discarded per hospital policy/procedure and disposal provisions. • For reusable devices, end of life is normally determined by wear and damage due to use. • We recommend the use of neutral pH detergents. Other detergents must be qualified to be compatible with surgical instruments and trays. • Note: The surface of anodized aluminum trays may suffer massively under non-neutral detergents/cleaners.
Processing Instructions Point of Use Care
• Devices should be covered with a towel dampened with sterile water to prevent blood and or debris from drying. Wipe blood and/or debris from device throughout surgical procedure to prevent it from drying onto the surface. • Flush cannulated devices with sterile water to prevent the drying of soil and/or debris inside. • Soiled devices should be separated from non-soiled devices to avoid contamination of personnel or surroundings.
Containment, Storage and Transport
• Soiled devices should be transported separately from non-soiled devices to avoid cross-contamination. • In case of return shipments, send only clean and sterilized products in sterile packaging. • The products must be: • Stored and transported only in appropriate approved sterile packaging (e.g. ISO 11607) • Protected from dust and dirt • Stored in a dry place, protected from moisture • Protected from temperature fluctuations and mechanical damage • Handled with great care and not be dropped or thrown
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Preparation for Decontamination
• • • • • •
Devices should be reprocessed as soon as it is reasonably practical. Disassemble devices, if applicable or required, prior to cleaning. Open devices with ratchets, box locks, or hinges. Remove sharp devices for manual cleaning or place into a separate tray. Lumens/cannulas of devices should be manually processed prior to cleaning. Presoak and/or rinse heavily soiled devices prior to cleaning to loosen dried soil or debris. Follow the enzymatic cleaner and detergent manufacturer’s instructions for use for correct exposure time, temperature, water quality, (i.e. pH, hardness) and concentration. • KLS-Martin L.P. devices should be cleaned separately from KLS-Martin L.P. instrument trays. Lids should be removed from cases for the cleaning process, if applicable. Equipment: • Soft-bristled brushes (Spectrum M16) and lumen brushes • Sterile syringes, pipettes, and/or water jet • Enzymatic cleaner & neutral detergent • Clean lint-free cloths & filtered pressurized air
CleaningManual Method
1. Disassemble devices, if applicable or required. 2. Rinse the devices under cool running tap water for a minimum of 2 minutes to remove gross soil. While rinsing, use a soft bristled brush (Spectrum M16) and/or lumen brush to aid in the removal of gross soil. 3. Prepare an enzymatic cleaner, such as Enzol®, per manufacturer’s recommendations at 1 oz/gallon using lukewarm tap water. 4. Fully immerse the devices in the prepared solution. Allow devices to soak for a minimum of 10 minutes. 5. Remove the devices from the solution and rinse under cool running tap water for a minimum of 2 minutes. 5.1. While rinsing, use an appropriately sized syringe to flush lumens, channels, and all hard to reach areas. 5.2. Actuate all movable device features through their full range of motion to ensure all areas are thoroughly rinsed. 6. Prepare a neutral detergent, such as Valsure® Neutral, per manufacturer’s recommendations at 1/4 oz/gal using lukewarm tap water. 7. Fully immerse the devices in the detergent solution. Thoroughly brush the devices for a minimum of 5 minutes using a soft-bristled brush (Spectrum M16) and/or lumen brush to remove all visible soil from the surface of the devices. Ensure to thoroughly brush all lumens, channels, and hard to reach areas. 7.1. Actuate all movable device features through their full range of motion to ensure all areas of the devices are exposed to the detergent solution. 8. Thoroughly rinse the devices using reverse osmosis/deionized (RO/DI) water for a minimum of 2 minutes. 8.1. While rinsing, use an appropriately sized syringe to flush lumens channels, and all hard to reach areas. 8.2. Actuate all movable device features through their full range of motion to ensure all areas are thoroughly rinsed. 9. Perform a final rinse on devices using RO/DI water. 10. Dry devices using a clean, soft, lint-free cloth & filtered pressurized air. 11. Visually inspect devices. Repeat the cleaning process if visible soil remains. Equipment: • Ultrasonic cleaner • FDA-cleared washer • Sterile syringes, pipettes, and/or water jet • Enzymatic cleaner & neutral detergent • Clean lint-free cloths & filtered pressurized air Note: Ultrasonic cleaning may cause further damage to devices that have prior surface damage. 1. 2.
CleaningMechanical Method
Disassemble devices, if applicable or required. Rinse the devices under cool running tap water for a minimum of 1 minute to remove gross soil. While rinsing, use a clean, lint-free cloth to aid in the removal of gross soil. 3. Prepare an enzymatic cleaner, such as Enzol®, per manufacturer’s recommendations at 1 oz/gallon using lukewarm tap water. 4. Fully immerse the devices in the prepared solution. Allow devices to soak for a minimum of 2 minutes. 5. While the devices are fully immersed, use a soft-bristled brush (Spectrum M16) and/or lumen brush to remove all visible soil from the surface of the devices. Actuate all movable device features through their full range of motion to ensure all areas of the devices are exposed to the detergent solution. 6. Remove the devices from the solution and rinse under cool running tap water for a minimum of 1 minute. 6.1. While rinsing, use an appropriately sized syringe to flush lumens, channels, and all hard to reach areas. 6.2. Actuate all movable device features through their full range of motion to ensure all areas are thoroughly rinsed. 7. Prepare a neutral detergent, such as Valsure® Neutral, per manufacturer’s recommendations at 1/4 oz/gal using lukewarm tap water in an ultrasonic cleaner. 8. Fully immerse the devices in the ultrasonic cleaner and sonicate for 15 minutes. 9. Thoroughly rinse the devices using RO/DI water for a minimum of 2 minutes. While rinsing, use an appropriately sized syringe to flush lumens, channels, and all hard to reach areas. 10. Transfer the disassembled devices into the washer for processing. The following parameters were validated using an FDA-cleared washer:
Phase
Minimum Time (minutes)
Minimum Temperature/Water
Detergent Type and Concentration
Pre-wash I Enzyme wash
02:00 02:00
Cold tap water Hot tap water
N/A Enzol® 1 oz/gal
Wash I
05:00
43°C
Valsure® Neutral ¼ oz/gal
RO/DI Rinse Drying
02:00 10:00
43°C 90°C
N/A N/A
11. Remove devices from the washer. 12. Dry the devices using a clean lint-free cloth. 13. Visually inspect each device. Repeat the cleaning process if visible soil remains.
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Detergents/ Cleaning Agents Used
Drying
Inspection and Functional Check
Enzol® and Valsure® Neutral were the cleaning agents used to validate the parameters in these instructions. KLS-Martin L.P. does not recommend any specific cleaning/disinfection agent. If a dry cycle is not included in the mechanical washer or if the device is not processed in a mechanical washer: • Dry each device thoroughly inside and out to prevent rust and malfunction. • Use a clean, soft, lint-free cloth to avoid damage to the surface. • Pay special attention to threads, ratchets and hinges or areas where fluid can accumulate. • Open and close devices so that all areas are reached. • Dry hollow parts using filtered pressurized air. KLS-Martin L.P. instruments must be inspected after processing and prior to sterilization in order to ensure proper function. Further use is confirmed by the successful inspection of the product. “Maintenance” refers to the targeted application of instrument oil (emulsion of white oil in water). Instruments with metallic sliding surfaces or connection parts must be treated with biocompatible steam-sterilizable care agents based on paraffin oil. Instruments must be lubricated following cleaning and prior to sterilization.
Maintenance
KLS offers the LubriPen®, REF 55-997-01-04, for the maintenance of surgical instruments. Instruments do not have an indefinite functional life because all reusable instruments are subjected to repeated stresses related to bone contact, impaction, and routine cleaning and sterilization processes. Damaged instruments should be replaced to prevent potential patient injury.
Packaging
We recommend the use of FDA-cleared sterilization packaging materials (e.g. wraps / pouches).
Sterilization must be performed in a validated steam sterilization process according to relevant AAMI/ASTM/ISO standards. Validation was performed in accordance with ISO 17665-1 and ISO 17665-2 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. The following instructions are recommended for sterile product: Sterile instruments must be stored in their original packaging in a place suitable for storing sterile supplies and may be removed from their packaging only immediately prior to use. Prior to use, check the packaging for use-by date and damage. If the expiration date is exceeded or the packaging is defective, do not use the product. Never reuse damaged and/or soiled instruments. If the end user chooses to reprocess opened product originally provided in sterile packaging, we recommend the validated steam sterilization parameters below.
Sterilization
For non-sterile product: Product must be sterilized and inspected for damage prior to use. The following recommendations are for the sterilization of KLS-Martin L.P. devices:
Cycle Type
Sterilization Exposure Time (minutes) at 132ºC (270ºF)
Minimum Dry Time*
Dynamic Air Removal
4
20 minutes
*Dry times may be highly variable due to the differences in packaging materials (e.g. non-woven wraps), environmental conditions,steam quality, device materials, total mass, sterilizer performance and varying cool down time. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying.
Additional Information
• The cleaning and sterilization information is provided in accordance with ANSI/AAMI ST81, ISO 17664, AAMI TIR30,AAMI TIR12, and ANSI/AAMI ST79. • The recommendations provided above have been validated by the medical device manufacturer as being capable of preparing a nonsterile KLS-Martin L.P. medical device. It remains the responsibility of the processor and/or hospital to ensure that the processing is actually performed when using equipment, materials, and personnel in the reprocessing facility in order to achieve the desired result. This requires validations and routine monitoring of the process. Likewise, any deviation by the processor and/or hospital from the recommendations provided should be properly evaluated for effectiveness and potential adverse consequences. • All users should be qualified personnel with documented expertise, competency, and training. Users should be trained on hospital policies and procedures along with current applicable guidelines and standards. • Users must wear appropriate personal protective equipment (PPE) when processing devices.
Manufacturer Contact
For further information, contact the KLS-Martin L.P. Customer Service Department at 904.641.7746 or 800.625.1557.
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SYMBOL GLOSSARY ISO 15223-1 Medical devices-Symbols to be used with medical device labels, labeling and information to be supplied. Part 1: General requirements SYMBOL
SYMBOL REF. NO.
SYMBOL TITLE
EXPLANATORY TEXT
5.1.6
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can be identified.
5.1.5
Batch code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
5.1.7
Serial Number
Indicates the manufacturer’s serial number so that a specific medical device can be identified.
5.4.3
Consult instructions for use or consult electronic instructions for use
Indicates the need for the user to consult the instructions for use.
5.4.2
Do not re-use
Indicates a medical device that is intended for one single use only.
5.2.7
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process.
5.1.4
Use-by date
Indicates the date after which the medical device is not to be used.
5.2.4
Sterilized using irradiation
Indicates a medical device that has been sterilized using irradiation.
5.2.8
Do not use if package is damaged and consult instructions for use
Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information.
OTHER SYMBOL(S) – NOT FROM STANDARDS SYMBOL
Rx ONLY
REFERENCE
TITLE
Labeling-Medical devices; 21 CFR 801.15(c)(1)(i)F prominence of required label statements. 21 CFR 801.109(b)(1)
SYMBOL TITLE
EXPLANATORY TEXT
Prescription only
Requires prescription in the United States.
Labeling-Prescription devices.
91-600-00-07 REV 22, 2023-10-09 4